NCT04048239

Brief Summary

Cochlear Implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

August 6, 2019

Last Update Submit

September 16, 2025

Conditions

Cochlear Hearing LossImplant

Keywords

cochlear implantroboticmini-invasive

Outcome Measures

Primary Outcomes (2)

  • cochlear implantation with the ROSA robot surgery time

    cochlear implantation with the ROSA robot surgery time

    during surgery, day 1

  • surgical quality based on material description and surgical technique

    surgical quality based on material description and surgical technique

    during surgery, day 1

Secondary Outcomes (4)

  • surgical quality based on robot precision

    during surgery, day 1

  • surgical quality based on the cochlear implantation in the cochlea

    during surgery, day 1

  • surgical quality based on intraoperative electrophysiological data

    during surgery, day 1

  • surgical quality based on pathological complications

    during surgery and postoperative period (1.5 month after surgery)

Interventions

cochlear implantationPROCEDURE

cochlear implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon.

computerized tomography (CT) scanOTHER

computerized tomography (CT) scan of the facial nerve

electromyographOTHER

electromyographic verification of the facial nerve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients eligible for cochlear implantation in CHU Amiens
  • patient more than 18 years old.

You may not qualify if:

  • malformation or significant antecedent of mastoidectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80000, France

Location

Related Publications (1)

  • Klopp-Dutote N, Lefranc M, Strunski V, Page C. Minimally invasive fully ROBOT-assisted cochlear implantation in humans: Preliminary results in five consecutive patients. Clin Otolaryngol. 2021 Nov;46(6):1326-1330. doi: 10.1111/coa.13840. Epub 2021 Aug 17. No abstract available.

    PMID: 34310841RESULT

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeProsthesis Implantation

Study Officials

  • Nathalie klopp-Dutote, MD

    CHU amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 7, 2019

Study Start

October 1, 2019

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)